FDA Medical Device Recalls (openFDA)
Beckman Coulter Inc.: UniCel DxH 800 Coulter Cellular Analysis System, Part Number: 629029. The UniCel DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel DxH 800 Analyzer provides a: (1) Complete Blood Count (CBC), Leukocyte 5 Part Differential (Diff), Reticulocyte (Retic) and Nucleated Red Blood Cell (NRBC) on whole blood; (2) Total Nucleated Count (TNC) and Red Cell Count (RBC) on Body Fluids (cerebrospinal, serous and synovial).
- Recall number
- Z-2145-2011
- Recalling firm
- Beckman Coulter Inc.
- Product
- UniCel DxH 800 Coulter Cellular Analysis System, Part Number: 629029. The UniCel DxH 800 Analyzer is a quantitative, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel DxH 800 Analyzer provides a: (1) Complete Blood Count (CBC), Leukocyte 5 Part Differential (Diff), Reticulocyte (Retic) and Nucleated Red Blood Cell (NRBC) on whole blood; (2) Total Nucleated Count (TNC) and Red Cell Count (RBC) on Body Fluids (cerebrospinal, serous and synovial).
- Status
- Terminated
- Initiated
- 2011-02-11
- Posted
- 2011-05-05
- Terminated
- 2014-09-02
- Reason
- The recall was initiated because the DxH 800 may fail to meet the carryover specification for the WBC Differential (DIFF) when the WBC is greater than 70 X 10 to the 3rd power cells/micro L (70 X 10 to the 9th power cells/L). Beckman Coulter indicated the DIFF% carryover is unlikely to have clinical impact.
- Root cause
- Other
- Action
- Beckman Coulter sent a Product Corrective Action (PCA) letter with attached Recall Response Form via US Postal Service on February 11, 2011, to all customers who have the affected instruments. Consignees were informed of the reasons for recall, the products affected and that a resolution for these issues would be corrected in a future release(s) for the DxH 800. Consignees were requested to complete and return the enclosed Response Form within ten (10) days and to share this information with your laboratory staff and retain this notification as part of your Quality System documentation. If consignees have transferred ownership or location of the analyzer(s) to another laboratory, they were requested to provide a copy of the letter to that party. For questions concerning this notice, Consignees were told to contact Beckman Coulter, Customer Service at (800) 526-7694 in the United States or Canada, or contact their local Beckman Coulter representative.
- Quantity
- 566 units
- Distribution
- Class 2 Recall - Worldwide Distribution -- USA, and the countries of : Canada, Australia, Macao, Belgium, Malaysia, Colombia, Myanmar, Croatia, Netherlands, Czech Republic, Norway, France, Philippines, Germany, Puerto Rico, Greece, Qatar,Hong Kong, Russian Federation, Hungary, Saudi Arabia, India, Singapore, Spain, Israel, taly Sweden, Japan, Switzerland, Korea, Turkey and United Kingdom.
- Lot, serial or model codes
- All Serial Numbers are affected.
- 510(k) numbers
- ["K081930"]
- PMA numbers
- not on file
- Product code
- GKZ
- Firm FEI
- 2050012
- Firm city
- Brea
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28